Miconazole Nitrate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Miconazole Nitrate
Generic name: MICONAZOLE NITRATE
Manufacturer: Actavis Pharma, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: aa9e250b-f317-42cb-b8d2-e85de56f4ef7
SPL ID: bb1aad58-4ca7-4be9-8649-0f29e22b81f5
Version: 10
Effective date: 2020-10-21
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:43

Harmonized routes table
Harmonized routes
VAGINAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	073508	derived:openfda.application_number
application number		ANDA073508	openfda.application_number
brand name		Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		Actavis Pharma, Inc.	openfda.manufacturer_name
ndc	package	0472-1738-03	openfda.package_ndc
ndc	product	0472-1738	openfda.product_ndc
ndc11	package	00472173803	derived:openfda.package_ndc
rxcui		992765	openfda.rxcui
spl id		bb1aad58-4ca7-4be9-8649-0f29e22b81f5	id
spl set id		aa9e250b-f317-42cb-b8d2-e85de56f4ef7	set_id
unii		VW4H1CYW1K	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 200 mg, 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1 . 3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0 . 5% incidence. The therapy-related dropout rate was 0 . 3%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.